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COMMUTE-aNCT04861259

A Study Evaluating the Efficacy, Safety, Pharmacokinetics and Pharmacodynamics of Crovalimab in Adult and Adolescent Participants With Atypical Hemolytic Uremic Syndrome (aHUS)

StatusActive, Not Recruiting
PhasePhase 3
Primary completion

At risk: Primary endpoint(s) modified.

See at-risk trials from Roche/Genentech

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Record History

The 50 most recent of 63 versions: 40 with changes below, 10 re-verified with no change. See every version on ClinicalTrials.gov ↗

  1. Results posted: Oct 30, 2026 Show 4 more changesShow less
    • Primary endpoint(s) modified
    • Eligibility criteria expanded, about 36 words
    • Study sites: 42 to 41
    • Secondary endpoints: 25 to 31
  2. Study sites: 43 to 42v61
  3. Study sites: 44 to 43v60
  4. Study sites: 45 to 44v59
  5. Study sites: 46 to 45v58
Show 35 earlier versionsHide 35 earlier versions
  1. Study sites: 50 to 46
    • Study completion date: Mar 15, 2029 to Aug 20, 2029
    v57
  2. Study sites: 55 to 50
    • Primary completion date: Sep 7, 2025 to Oct 9, 2025
    v56
  3. Study sites: 56 to 55
    • Primary completion date: Jun 13, 2025 to Sep 7, 2025
    • Study completion date: Jun 15, 2029 to Mar 15, 2029
    v55
  4. Study sites: 65 to 56v54
  5. Trial status: Recruiting to Active, Not Recruiting
    • Enrollment target: estimated 80 to confirmed 83
    • Study sites: 70 to 65
    v53
  6. Site details revised at 2 of 70 sitesv51
  7. Site details revised at 1 of 70 sitesv49
  8. Study sites: 73 to 70v48
  9. Site details revised at 2 of 73 sitesv44
  10. Eligibility criteria shortened, about 8 words
    • Study completion date: Dec 7, 2029 to Jun 15, 2029
    • Secondary endpoints: 23 to 25
    • Site details revised at 4 of 73 sites
    v43
  11. Site details revised at 1 of 73 sitesv42
  12. Site details revised at 2 of 73 sitesv40
  13. Study sites: 72 to 73v39
  14. Study sites: 71 to 72v38
  15. Study sites: 70 to 71v37
  16. Study sites: 69 to 70v36
  17. Study sites: 67 to 69v35
  18. Site details revised at 2 of 67 sitesv34
  19. Site details revised at 1 of 67 sitesv32
  20. Study sites: 66 to 67v31
  21. Site details revised at 6 of 66 sitesv30
  22. Study sites: 65 to 66v29
  23. Primary completion date: Mar 8, 2024 to Jun 13, 2025v28 Show 5 more changesShow less
    • Eligibility criteria expanded, about 20 words
    • Enrollment target: 90 to 80
    • Study completion date: Jun 14, 2028 to Dec 7, 2029
    • Secondary endpoints: 24 to 23
    • Site details revised at 2 of 65 sites
  24. Site details revised at 3 of 65 sitesv27
  25. Site details revised at 1 of 65 sitesv26
  26. Study sites: 64 to 65v24
  27. Study sites: 63 to 64v23
  28. Study sites: 62 to 63v22
  29. Study sites: 60 to 62v21
  30. Study sites: 58 to 60v20
  31. Site details revised at 1 of 58 sitesv19
  32. Eligibility criteria expanded, about 17 words
    • Study sites: 56 to 58
    • Study completion date: Jun 25, 2027 to Jun 14, 2028
    v18
  33. Study sites: 54 to 56v16
  34. Site details revised at 1 of 54 sitesv15
  35. Study sites: 50 to 54v14
  • Notable: the plan changed
  • Minor: routine updates

Endpoints

Primary

Naive Cohort: Percentage of Participants With Complete Thrombotic Microangiopathy Response (cTMAr) Anytime From Baseline to Week 25
Timeframe: Baseline up to Week 25 (after 24 weeks on treatment)

Secondary (31)

Naive and Switch Cohorts: Percentage of Participants Requiring Dialysis at Baseline and at Week 25 Who Completed 24 Weeks of Treatment
Naïve and Switch Cohorts: Percentage of Participants With Change From Baseline to Week 25 (After 24 Weeks on Treatment) on Dialysis Status (Yes/No)
Naive and Switch Cohorts: Observed Values of Estimated Glomerular Filtration Rate (eGFR), as Calculated From Central Serum Creatinine
Naive and Switch Cohorts: Change From Baseline up to Week 25 in eGFR, as Calculated From Central Serum Creatinine
Naive and Switch Cohorts: Percentage of Participants With Change in Chronic Kidney Disease (CKD) Stage From Baseline to Week 25, as Assessed Based on eGFR Calculated From Central Serum Creatinine
Show 26 moreShow less
Naive and Switch Cohorts: Observed Value of Platelet Count
Naive and Switch Cohorts: Observed Value of Lactate Dehydrogenase (LDH)
Naive and Switch Cohorts: Observed Value of Hemoglobin
Naive and Switch Cohorts: Change From Baseline in Platelet Count at Week 25
Naive and Switch Cohorts: Change From Baseline in LDH at Week 25
Naive and Switch Cohorts: Change From Baseline in Hemoglobin at Week 25
Naive and Switch Cohorts: Change From Baseline in Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-Fatigue) Score at Week 25
Naive Cohort: Percentage of Participants With Platelet Count ≥ LLN at Two Separate Assessments, Obtained at Least 4 Weeks Apart (Minimum of 26 Days), by Week 25 (After 24 Weeks on Treatment)
Naive Cohort: Percentage of Participants With LDH ≤ Upper Limit of Normal (ULN) at Two Separate Assessments, Obtained at Least 4 Weeks Apart (Minimum of 26 Days), by Week 25 (After 24 Weeks on Treatment)
Naive Cohort: Percentage of Participants With ≥25% Decrease in Serum Creatinine From Baseline at Two Separate Assessments, Obtained at Least 4 Weeks Apart (Minimum of 26 Days), by Week 25 (After 24 Weeks on Treatment)
Naive Cohort: Time to Complete Thrombotic Microangiopathy Response (cTMAr)
Naive Cohort: Duration of cTMAr
Naive Cohort: Percentage of Participants With cTMAr Ongoing at Week 25
Switch Cohort: Percentage of Participants With Maintained Thrombotic Microangiopathy Control (mTMAc) From Baseline Through Week 25 (After 24 Weeks on Treatment)
All Cohorts: Number of Participants With AEs
All Cohorts: Number of Participants With Injection-Site Reactions, Infusion-Related Reactions, Hypersensitivity, Malignant Hypertension and Infections
All Cohorts: Number of Participants With AE Leading to Study Drug Discontinuation
Switch Cohort: Number of Participants With Clinical Manifestations of Drug-target-drug Complexes (DTDCs)
All Cohorts: Crovalimab Serum Concentration
All Cohorts: Percentage of Participants With Anti-Drug Antibodies (ADAs) to Crovalimab
All Cohorts: Observed Value of Complement Activity (CH50) Over Time, as Measured by Liposome Immunoassay (LIA)
All Cohorts: Change From Baseline in CH50 Over Time, as Measured by LIA
All Cohorts: Observed Value of Free Complement Component 5 (C5) Concentrations in Crovalimab-treated Participants
All Cohorts: Change From Baseline in Free C5 Concentrations Over Time in Crovalimab-treated Participants
All Cohorts: Observed Value of Total C5 Concentrations in Crovalimab-treated Participants
All Cohorts: Change From Baseline in Total C5 Concentrations in Crovalimab-treated Participants

Arms and interventions

CrovalimabExperimental

Participants will be enrolled in three cohorts: \[1\] Naive Cohort - participants who have not been previously treated with complement inhibitor therapy; \[2\] Switch Cohort - participants who switch to crovalimab from another Complement Component 5 (C5) inhibitor and \[3\] C5 Single Nucleotide Polymorphism (C5 inhibitor) Cohort - participants with documented C5 polymorphism.

Drugs: Crovalimab

Sites

41 sites in 16 countries

United States 6, Germany 4, Mexico 4, Turkey (Türkiye) 4, Brazil 3, France 3, Israel 3, Japan 3, Spain 3, Italy 2, Belgium 1, Canada 1, China 1, Hungary 1, India 1, Poland 1